Hemorrhoidal
- Product NDC
- 42507-944
- 11-digit product format
- 425070944
- Labeler code
- 42507
- Product ID
- 42507-944_cfe1c8bb-b48e-4329-8c1b-b93e75b02d56
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- glycerin, phenylephrine HCl, pramoxine HCl, white petrolatum
- Dosage form
- CREAM
- Route
- TOPICAL
- Labeler
- HyVee Inc
- Application
- M015
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2008-08-11
- Substance
- GLYCERIN; PHENYLEPHRINE HYDROCHLORIDE; PRAMOXINE HYDROCHLORIDE; PETROLATUM
- Active strength
- 14.4; .25; 1; 15 g/100g; g/100g; g/100g; g/100g
- Pharmacologic classes
- Adrenergic alpha1-Agonists [MoA], Allergens [CS], Cell-mediated Immunity [PE], Glycerol [CS], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Chemical Allergen [EPC], alpha-1 Adrenergic Agonist [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Observed NDC auxiliary status history#
This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
| Captured / source date | Dataset | Scope | Package NDC | Snapshot | Source SHA-256 |
|---|---|---|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded product | product | d630ba8d3edf… | 732f749b63fb… | |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 42507-944-24 | d630ba8d3edf… | 732f749b63fb… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded product | product | f5e01cc5f278… | a2eaf40c39c3… | |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 42507-944-24 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded product | product | 2ef7874e63bc… | 57b86245f4fa… | |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 42507-944-24 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded product | product | a1b67e2a42f9… | c4cf2c586c0d… | |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 42507-944-24 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded product | product | cfe11265f3b6… | 090c488252e2… | |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 42507-944-24 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded product | product | cdf11ea48f46… | ba0047e9e063… | |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 42507-944-24 | cdf11ea48f46… | ba0047e9e063… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded product | product | 302b2466d912… | e7b80fea0513… | |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 42507-944-24 | 302b2466d912… | e7b80fea0513… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded product | product | ed331223b511… | 672a5bd82f5f… | |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 42507-944-24 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded product | product | 0efc9e666f02… | f202fb6c5f17… | |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded package | package | 42507-944-24 | 0efc9e666f02… | f202fb6c5f17… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded product | product | ad56d346431e… | cc804d4bbf1e… | |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded package | package | 42507-944-24 | ad56d346431e… | cc804d4bbf1e… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded product | product | 367a005e9d99… | 383a685ebd0f… | |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded package | package | 42507-944-24 | 367a005e9d99… | 383a685ebd0f… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded product | product | 557ba5c1ecfa… | 9c80585c8c6e… | |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded package | package | 42507-944-24 | 557ba5c1ecfa… | 9c80585c8c6e… |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Hemorrhoidal
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| GLYCERIN | 14.4 g/100g |
| PHENYLEPHRINE HYDROCHLORIDE | .25 g/100g |
| PRAMOXINE HYDROCHLORIDE | 1 g/100g |
| PETROLATUM | 15 g/100g |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| PDC6A3C0OX | Internal UNII lookup |
| 04JA59TNSJ | Internal UNII lookup |
| 88AYB867L5 | Internal UNII lookup |
| 4T6H12BN9U | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 1293649 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| b867f691-7a13-4659-b664-06aa36899310 | Available on FDA.report |
DailyMed Socrata Ingredients#
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Signature Numb cream | 5% LIDOCAINE | Shengnan (Guangzhou) Cosmetics Co., LTD | 3d2ecb86-6bb1-2528-e063-6394a90a8d89 | 2025-08-25 | Warnings | M015 |
| Cooling Perineal Pad Liners | COOLING PERINEAL | ELEEO BRANDS LLC | 29a433bc-a833-ffc7-e063-6294a90a465a | 2025-08-25 | Warnings | M015 |
| Signature numbing cream | 5% LIDOCAINE | Shengnan (Guangzhou) Cosmetics Co., LTD | 3d3b771f-5e30-b23e-e063-6294a90a3fb2 | 2025-08-25 | Warnings | M015 |
| Exchange Select Hemorrhoidal | MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL | Army & Air Force Exchange Service | 6c32af3e-5b60-4e3e-95c2-ada37a7d3b2a | 2025-08-22 | Warnings | M015 |
| Hemorrhoidal | MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL | Padagis Israel Pharmaceuticals Ltd | 43826c68-0a20-460d-a7b5-f3e12395a7d0 | 2025-08-22 | Warnings | M015 |
| Barrier Protectant Cream | BARRIER CREAM | Cardinal Health | 539d9aac-75cf-4efd-bb3e-b465563304ca | 2025-08-21 | Warnings | M015 |
| Lidocaine Patch | LIDOCAINE 4% | SLV PHARMACEUTICALS LLC DBA AUM PHARMACEUTICALS | 0a31ba9a-8283-4bf8-b6c6-6e331465622f | 2025-08-20 | Warnings | M015 |
| VBBV Anorectal(Hemorrhoidal) Creams | LIDOCAINE | Jiashen International Trading Co., Ltd. | 3cba84ea-5ee0-7ee3-e063-6294a90af11b | 2025-08-19 | Warnings | M015 |
| Hemorrhoidal | MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL | Publix Super Markets Inc | 7b360d3b-fb2b-4f35-a04d-203dd352933d | 2025-08-19 | Warnings | M015 |
| Good Sense Hemorrhoidal | MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL | L. Perrigo Company | 2492ee1b-01f1-46e7-8790-b6ebc48f2aff | 2025-08-19 | Warnings | M015 |
| Norms Hemorrhoid | PHENYLEPHRINE HYDROCHLORIDE, WITCH HAZEL | Totally Normal Company | 3c98cc12-2476-9f73-e063-6394a90a6f23 | 2025-08-17 | Warnings | M015 |
| Upside Down Pain Relief | BENZOCAINE, GLYCERIN | Fridababy, LLC | 31c2cd25-1fec-5ec5-e063-6394a90a24b4 | 2025-08-15 | Warnings | M015 |
| DG Health Hemorrhoidal | MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL | Dolgencorp, LLC | d9f12a34-7bd1-4ba5-b34b-1b641f58271a | 2025-08-12 | Warnings | M015 |
| Norms Hemorrhoid | GLYCERIN, LIDOCAINE, PETROLATUM, PHENYLEPHRINE HCL | Totally Normal Company | 3bdf8c74-3db6-1805-e063-6394a90aaba0 | 2025-08-08 | Warnings | M015 |
| Asteroid | MENTHOL, PETROLATUM, ZINC OXIDE | HEALTHTEX LIMITED | 29d1e46d-0189-4f9e-9963-8a9de2757f28 | 2025-07-30 | Warnings | M015 |
| Comfort Candy Hemorrhoidal | LIDOCAINE, PHENYLEPHRINE HYDROCHLORIDE | BOWLER ESTHETICS, INC | 4951d984-3e86-4eb6-9505-2c506e22fda2 | 2025-07-23 | Warnings | M015 |
| Doctor Butler Hemorrhoid and Fissure Advanced Formula | GLYCERIN 37.5%, LANOLIN 12.5%, LIDOCAINE 4%, ZINC OXIDE 5% | Beyond Health, PA | d2a769e2-afd0-aed2-e053-2995a90ad429 | 2025-07-23 | Warnings | M015 |
| Dr Butlers Hemorrhoid | WITCH HAZEL 50% | Beyond Health, PA | 3a9fea0c-b189-c77e-e063-6294a90a0583 | 2025-07-23 | Warnings | M015 |
| Dr Butlers Advanced Hemorrhoid Relief | LIDOCAINE HCL 5%, PHENYLEPHRINE HCL 0.25%, WITCH HAZEL 50% | Beyond Health. PA | 3aa0ee7a-3863-254d-e063-6394a90ad40e | 2025-07-23 | Warnings | M015 |
| Dr. Butler Hemorrhoid Treatment | PHENYLEPHRINE HYDROCHLORIDE 0.25%, WITCH HAZEL 50% | Beyond Health P.A. | d2d1c81c-6443-c4b7-e053-2995a90a14d7 | 2025-07-22 | Warnings | M015 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 42507-944-24 | 42507094424 | 1 TUBE in 1 CARTON (42507-944-24) / 51 g in 1 TUBE (42507-944-51) | 1 tube | 2008-08-11 | No | No | Current |